ALINITY I FREE T4 REAGENT KIT

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). 1ST RUN ON (B)(6) 2025 RESULT: 0.63, 2ND RUN ON (B)(6) 2025 RESULT: 1.12, 3RD RUN ON (B)(6) 2025 RESULT: 1.02 / 0.97 / 0.88. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION B5 - DESCRIBE EVENT OR PROBLEM: THIS SECTION WAS UPDATED WITH UNIT OF MEASURE. THE DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORTED THE COMPLAINT ISSUE WITHOUT INDICATION OF ANY ADDITIONAL ISSUES. A SEARCH FOR SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 71598UD00. A REVIEW OF TRACKING AND TRENDING FOR THE ALINITY I FREE T4 ASSAY DID NOT IDENTIFY ANY TRENDS RELATED TO THE COMPLAINT ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY NON-CONFORMANCES, POTENTIAL NON-CONFORMANCES OR DEVIATIONS WITH LOT NUMBER 71598UD00 AND THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS PERFORMED UTILIZING RETAINED REAGENT KIT OF THE COMPLAINT LOT. ALL TESTING PASSED INDICATING THE REAGENT LOT IS PERFORMING AS EXPECTED. A REVIEW OF LABELING WAS PERFORMED AND FOUND TO SUFFICIENTLY ADDRESS THE CUSTOMER¿S ISSUE. BASED ON OUR INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I FREE T4 REAGENT, LOT NUMBER 71598UD00.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY DEPRESSED ALINITY I FREE T4 RESULTS FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). 1ST RUN ON (B)(6) 2025 RESULT: 0.63, 2ND RUN ON (B)(6) 2025 RESULT: 1.12, 3RD RUN ON (B)(6) 2025 RESULT: 1.02 / 0.97 / 0.88. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. UNIT OF MEASURE: NG/DL.